Pancreum Progress Report: Wearable Closed-Loop System Now a Prototype

Written by Mike Hoskins
| Published on August 25, 2014

Remember that little circular, three-wedge closed-loop device known as Pancreum? You know, the Artificial Pancreas system in which you pop in wedges for insulin pumping, CGM (continuous glucose monitoring), and glucagon pumping, all around a little central core controller?

We've been watching the novel Pancreum system move forward since it won our innovation design contest in 2011, and although no advancements have been announced to the public, there's been a lot going on behind the scenes.

Now it's great to hear from Pancream founder Gil de Paula that his team has developed a working prototype of the potential multi-piece AP device. Novel medical devices always take a long time to develop, especially for small independent outfits that don't have the resources and deep pockets of Big Pharma. Since starting this whole venture, de Paula has moved the home base of Pancreum development from Florida to San Francisco, in part to be closer to tech talent and key contacts.

"We're not just a computer-generated image anymore, there's a real prototype behind it now," Gil told us in a recent phone chat. "People we've met with have been surprised and happy to see it's real, not just a concept."

In the past few years since Pancreum's concept came on the scene, a lot has changed -- from more advanced CGM tech, to increased mobile health and Bluetooth connectivity, to many advances in trial AP systems. Not to mention the advancement in stable glucagon formulas and all the AP studies that have been making headlines.

Pancreum's prototype, nicknamed Genesis, is making great headway, Gil tells us. "This isn't science fiction, and it's very doable within a reasonable time frame. Maybe there's one more design cycle and then we're looking to do animal trials."

Talking Tech

Gil is now working on developing the CGM wedge with Oregon-based iSens, which has been working on a minimally invasive CGM sensor for the better part of two decades now. The company had been bought by Bayer years ago, but after the nation's financial crisis, that Big Pharma player opted not to market the iSens CGM sensor and sold the product rights back.

"Their sensor is great and we're forming a partnership with them," Gil said, adding that he's also interested in talking to any other CGM companies that might be interested.

His team has created an easy push-button insertion mechanism that allows you to simply put the device onto your skin and push the sides to make it click into place. And there's a push-button bolus delivery, something Insulet's OmniPod (the only full-featured patch pump on the market right now) does not have, meaning users have to go back to injections if they lose the OmniPod controller unit, called the Personal Diabetes Manager (PDM).

"In our case, you keep the pump on and there's push-button feedback via beeping that lets you navigate what you need," Gil said.

There's also a wireless mHealth component, of course. An iOS app's been developed with an appealing graphical user interface and next up is Bluetooth communication for that platform, as well as the integration of a blood glucose meter and the completion of the CGM wedge's electronic interface.

Long before the birth of the actual #WeAreNotWaiting movement, Gil himself wasn't waiting and had ideas that many in D-Community thought were a little far-fetched -- including open-source data integration. He's planned from the start to publish the protocols from his device and share that information with entities like Tidepool, which has been making strides in bringing D-data together.

"A lot of people questioned this in the beginning, asking whether it was realistic to talk about novel glucagon and smartphone apps with low-glucose suspend," Gil said. "Things change, and you could see it coming many years ago... Some of these predictions came true, and our own future has become more certain and realistic."

How soon could we see a Pancreum animal trial and eventually human trials for regulatory review? Probably not anytime soon; we're talking years here. Once again, these D-tech developments take time.

Making Money

And so much depends on funding. Right now, Gil has been largely funding Pancreum on his own and from a few private donors, and that small group has spent roughly $200,000 so far. To earn more, Gil has been doing some side-work and tapping into his engineering experience on other cool tech that's been making news but has no diabetes connection.

Notably, he helped design the digital credit card replacement known as COIN, which was announced in November and is almost ready to hit the market. That credit card-sized device stores up to eight credit, debit, gift, or membership cards and lets you switch between them by pressing a circular button on its surface. From there, you just swipe the COIN in a card-reader just like you would with any traditional card.

Gil's also been working with Mechio Inc. in San Francisco to create a Bluetooth smartphone-enabled "stealth" wearable fitness device called Motiv, which would use health sensors to track fitness and movements and other health info like body temp and oxygen levels.

Those tech ventures help Gil fund what he's doing with Pancreum, and he makes a point to say his other work doesn't mean Pancreum development is slowing down or moving to the back-burner.

"It's cool to be involved in those other types of devices and tech, and it not only brings money to what we want to create with Pancreum but also helps us network with others in the industry," he said.

Aside from the Pancreum wedge system, Gil says he's working on another device that would be a stand-alone insulin delivery system, not too dissimiliar from OmniPod -- but that's in addition to his Genesis prototype and Gil isn't ready to share more on that publicly yet.

So will Pancreum become a real product soon? Not super-soon, for sure. But it's looking like a lot more than a pipedream, and we can't say enough how much we appreciate the work of people like Gil.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community.
The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines.
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Archived Comments

Ruth|2014-08-25

He needs to do a Tube Tube video like the ALS.Any creative and unique ideas anyone?

Gil DePaula|2014-08-25

The glucose sensor partner company is iSense:http://www.diabetesmine.com/2008/10/isense-and-their-glycemic-signature.html

Gil DePaula|2014-08-25

Hi Ruth, thank you for the feedback. We have a video on YouTube that shows the system and its multiple configurations:https://www.youtube.com/watch?v=kAbOMi9wK_cYou can also go to our website and read about what we are doing:www.pancreum.com

Dan|2014-08-25

Here is my take: We will be talking about this ten years from now. A closed end loop system that sits outside of us that uses the same old insulin we have now is not going to pass through FDA approval. Once these things hit the real world, you can imagine how many various episodes of hypoglycemia and hyperglycemia are going to be reported. If there is any hope in the horizon, it is from something like nanotechnology such as SmartInsulin. This closed end loop is not smart. Nobody has put one through the ringer yet--a month on a person eating like people do without diabetes and various activity levels throughout the day.

Tim Brand|2014-08-25

I really enjoyed meeting Gil last year at ADA and getting to know him. I'm very impressed with his vision and heart to help people withType 1 Diabetes. I wouldn't mind seeing my girls wearing a Genesis. Good article Mike, keep up the great work Gil. Tim.

Gil dePaula|2014-08-26

Hi Tim,Thank you, and nice to hear from you. I hope your princesses are doing well.Cheers,Gil

Gil DePaula|2014-08-26

Hi Dan,Thank you for the feedback.Several of such trials have been done, for several days, in which people ate as much as they would like and exercised as much as they wanted, and virtually no cases of hyperglycemia nor hypoglycemia occurred. Search on the web, especially for the trials conducted by Dr. Russell and Dr. Damiano in Boston. At the ADA I met a woman who took part in one, and she told me that at first she couldn't believe her glucose level was always near the target, and that after a few days sometimes she would even forget she had T1D. She said that she literally cried when the trial ended and she couldn't wear it anymore. Of course, they don't have a device like the Genesis yet, so they typically use 2 Tandem t-slim or OmniPod pumps and a Dexcom CGM, all controlled from a smartphone app.You can see what they accomplished in one of those trials here (on very active kids!):http://diatribe.org/issues/62/conference-pearls.. but there are many more... just google it. :)Cheers,Gil

Dan|2014-08-26

A mean glucose of 133 is poor control in my book. That means, with standard deviation being factor in, these people are probably running around 100 to 180 at all times. I run, the majority of the day below 120 and have an A1C of 5.0. I will not risk my life having this computer run my diabetes for me with such poor results. They can define hyperglycemia any way they want. But the reality is, hyperglycemia is anything above 120. That is defined by your body.So, I stand in my prediction, that these devices will not control blood sugar in the normal range. 133 mean is far from normal.But, you do not care about running 6.0 and above A1c, go for it, it is your life.

Doug|2014-08-27

Dan, Cudos to meeting your goals however. Some would say an average BG under 100 (A1c of 5.0) for a type 1 has its own dangers. Immediate permanent dangers. And likely endangers others around you if you drive or operate any machinery. But as you said Go for it Its your life.

Bernard Farrell|2014-08-27

Very exciting to hear that work is moving forward. I'm especially happy that Pancreum will be publishing the data protocols, all device makes should be doing this.Best of luck with more funding.

Dan|2014-08-27

Who is this "some would say." Whoever told you that does not what they are talking about. Are you kidding? A1c is an advanced glycation end product. Aging of all organs and organ system increases when glycation is accelerated. Any A1c above 6.0 is dangerous. Don't believe anyone who states a glucose level between 70-100.Lab reference for normal blood glucose is 65-99 mg/dl. That is a fact. It cannot be ignored. Yes, 65 is normal.

Dr. Dave|2014-08-28

Dan - you seem to have some issues. Glycemic control that tight (A1c of 5) is associated with poor outcomes in Type 1 diabetics. Furthermore, suggesting that Type 1 diabetics can or should try to achieve an A1c that low is dangerous and probably discouraging. As has been pointed out, these types of artificial pancreases have indeed been tried in the real world, and I'd say this is the most promising thing since the first successful synthesis of insulin. The introduction of glucagon makes the system awfully close to what a real pancreas does. The only missing link is the fact that the glucose sensed is that in the peripheral circulation rather than the portal circulation. Other systems (and hopefully this one as well) use machine learning and Bayesian prediiction to learn what works well for an individual patient. (Machine learning was the first thing I thought of when I heard of the artificial pancreas - if you can teach a computer to learn the physics behind kicking a soccer ball, you can teach a computer to learn how an individual responds to insulin and glucose.)It's an exciting time for those of us who treat Type 1 diabetes, and undoubtedly much more exciting for those who have it.Dave S.

Alice|2014-09-21

I have been living with omnipod for the past 4 years and I love it. I have been type 1 for 10 y and usually running at hba1c around 7% on average which is comfortable. Great work Gil, exciting to see such development are being made and looking fw to hearing more! What about crowdfunding?Good luck Alice

Natalie Hodge|2014-10-05

I agree Gil! We had great success in our crowdfunding campaign with Medstartr last year. There are certainly other sites you could consider for this. You could even run your own crowdfunding campaign a la tile. Adding in a viral "challenge" like als concurrently would add to it! We will all be there to back you! Seriously now that the AP data is coming in and looking so promising, we must have the hardware to go with it! I am also wondering about rock health for you now that you are Bay Area? This may be an issue of market size, the t1 market being a relatively small market (as opposed to t2 matket). Let us know what we can do to help! Best, natalie

Gil DePaula|2014-11-12

Crowd-funding has already been tried by us on Indiegogo. Unfortunately the problem is that nobody is willing to give money and potentially not be getting anything in return, or having to wait 3 years before getting it, i.e. please remember that it needs FDA approval before it can be shipped. We asked for $500 K to complete the prototype and got $2 K.

Martin Woodworth|2014-12-20

I live in England. I have been type 1 for nearly 31 years.I have been having trouble with night time hypos so have just recently learned about cgm systems that can warn me.I will probably buy a Dexcom G4 or Abbott Navigator 2 as they both get good reviews & are available.But your Genesis prototype sounds fantastic & exactly what is required.If it was available now I'd get one!If you want an Englishman to trial it then I'd happily do it :)Brilliant stuff & all the best.

Gil dePaula|2014-12-29

Hi Martin,Thank you for being supportive.You can stay in touch via gdepaula@pancreum.com if you'd like.Happy New Year to all.Cheers,Gil

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